PENNCHLOR 64- chlortetracycline hydrochloride powder

Pennchlor 64 by

Drug Labeling and Warnings

Pennchlor 64 by is a Animal medication manufactured, distributed, or labeled by Pharmgate Animal Health, Pharmgate LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RESIDUE WARNING

RESIDUE WARNINGS

Do not administer to chickens within 24 hours of slaughter. Do not use in laying chickens. Do not administer to growing turkeys within 24 hours of slaughter. Zero day withdrawal in swine. Do not administer to cattle within 24 hours of slaughter. Do not use in lactating dairy cattle. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.

DOSAGE & ADMINISTRATION

GENERAL INFORMATION ON DOSAGE

Dosages in terms of packets per 512 gallons are based on stated dosages per unit of body weight and average water consumption of the species. Weather conditions, ambient temperature, humidity, age, class of livestock and other factors may affect consumption and, except where calves are drenched, the unit dosage should be used as a guide to effective use in drinking water. Animals must actually consume enough medicated water to provide the desired therapeutic dose under the conditions that prevail.

PRECAUTIONS

Use as the sole source of chlortetracycline. Prepare fresh solutions daily. When used in plastic or stainless steel waterers or automatic waterers, prepare fresh solutions every 24 hours. This product has not been demonstrated to provide adequate stability in galvanized waterers. Stability loss may reduce effectiveness of the product. Do not administer in milk or milk replacers. When feeding milk or milk replacers, administration one hour before or two hours after feeding is recommended.

VETERINARY INDICATIONS

Indications and Directions For Use

Chickens	Dose
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.	200-400 mg/gal (1-2 packets/512 gallons). This is equivalent to ¼ - ½ oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full 24-hour period. Administer 7 to 14 days.
Control of Chronic Respiratory Disease (CRD) and air-sac infections caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline.	400-800 mg/gal (2-4 packets/512 gallons). This is equivalent to ½ - 1 oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full 24-hour period. Administer 7 to 14 days.
Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.	1000 mg/gal (5 packets/512 gallons). This is equivalent to ¼ oz of powder per 1 gallon of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full 24-hour period. Administer 7 to 14 days.

Growing Turkeys	Dose
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.	400 mg/gal (2 packets/512 gallons). This is equivalent to ½ oz of powder per 5 gallons of water. Mix until dissolved. Administer at this rate in the total water consumed over a full 24-hour period. Administer 7 to 14 days.
Control of complicating bacterial organisms associated with Bluecomb (transmissible enteritis or coronaviral enteritis) susceptible to chlortetracycline.	25 mg/lb body weight/day (1 packet for every 4,096 lbs of turkeys). ⅛ oz treats a 20 lb turkey for one day. Mix until dissolved. Administer in the total water consumed over a full 24 hour period. Administer 7 to 14 days.

Medicate chickens and turkeys continuously at the first clinical signs of disease and continue for 7 to 14 consecutive days. The dosage ranges permitted provide for different levels based on the severity of the infection. If improvement is not noted in 24-48 hours, consult a veterinarian or a diagnostic laboratory to determine diagnoses and for advice regarding the optimal level of the drug where ranges are permitted.

Swine	Dose – 10 mg/pound body weight daily
Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasturella spp., Actinobacillus pleuropneumoniae, and Klebsiella spp. susceptible to chlortetracycline.	(5 packets/512 gallons will treat 512 100-lb pigs per day). ¼ oz of powder will treat a 100 lb pig for one day. Mix until dissolved. Administer at this rate in the total water consumed over a full 24-hour period. Administer for 3 to 5 days.

Calves, Beef Cattle and Non-Lactating Dairy Cattle	Dose – 10 mg/pound body weight daily
Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasturella spp., Histophilus spp., and Klebsiella spp. susceptible to chlortetracycline.	Use ½ oz. of powder for each 200 lbs of calf weight, per day. Mix until dissolved. Administer at this rate in the total water consumed over a full, 24-hour period, or as a drench in divided doses. Administer 3 to 5 days.

Water Medicators: Dissolve the contents of one 25.6 oz packet in 100 oz of fresh water to prepare a stock solution, that when metered at the rate of 1 oz per gallon of drinking water, will deliver 1000 mg of chlortetracycline HCl per gallon. At this rate, a gallon of drinking water will treat a 100 lb pig or a 100 lb calf at the rate of 10 mg per lb of body weight for one day.

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PRINCIPAL DISPLAY PANEL - 725.7 g Packet Label

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Pennchlor 64®

(chlortetracycline HCl)
Soluble Powder Concentrate

CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.

Antibiotic
For Animal Use in Drinking Water
Chlortetracycline hydrochloride, 64 g per pound

This 25.6 oz packet contains 102.4 g
chlortetracycline HCl (64 g/lb) and will
make the resulting concentrations:

Gallons	Chlortetracycline HCl per Gallon
1024	100 mg
512	200 mg
256	400 mg
102.4	1000 mg

Net Contents: 25.6 oz (725.7 g)

ANADA 200-295, Approved by FDA
Not for Use in Humans.
Store at controlled room temperature 15°C to 30°C
(59°F to 86°F)
#F64-1 Rev. 4/18

Pharmgate
ANIMAL HEALTH

Marketed by:
Pharmgate Animal Health, LLC
14040 Industrial Road
Omaha, Nebraska 68144

INGREDIENTS AND APPEARANCE

PENNCHLOR 64 
chlortetracycline hydrochloride powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 51429-064
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlortetracycline Hydrochloride (UNII: O1GX33ON8R) (Chlortetracycline - UNII:WCK1KIQ23Q)	Chlortetracycline Hydrochloride	0.141 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51429-064-01	725.7 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200295	04/27/2001

Labeler - Pharmgate Animal Health (833270817)

Registrant - Pharmgate LLC (079628671)